Respiratory Distress Syndrome, AdultNCT00429637
Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Syncytial Virus Infections, run by University of Virginia at 1 site in United States.
Trial summary
Given the possible prognostic relationship between exhaled breath condensate pH and clinical symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the intensive care unit. Read more about this study
- Who is it for?
- Ages 1 hour and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Respiratory Syncytial Virus Infections, Pneumonia
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any intubated patients, aged birth to adulthood, who are on a ventilator in any University of Virginia (UVA) intensive care unit.
Who cannot join
- Control subjects may not be taking oral or inhaled steroids or have asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bacterial or viral pneumonitis, or adult respiratory distress syndrome (ARDS).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Brian K Walsh, BS, RRT, 434-243-9324, bkw2j@virginia.edu
John F Hunt, MD, 434-243-9324, jhunt@virginia.edu
About this study
Official title: Phase 2 Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
Given the possible prognostic relationship between exhaled breath condensate pH and clinical symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the intensive care unit. For example, if exhaled breath condensate pH falls prior to the onset of clinical symptoms, it is likely that it can be useful as an early marker, heralding the onset of various inflammatory lung diseases. Specifically, exhaled breath condensate pH could be used as a safe, non-invasive screening tool for Ventilator Associated Pneumonia. Similarly, just as changes in exhaled breath condensate pH might predict the onset of disease, exhaled breath condensate pH changes might also mark the progression or resolution of disease (e.g. alerting clinicians to possible readiness for extubation). Although such notions are hypothetical, they are beginning to be supported by anecdotal evidence.
Read the detailed description
The investigators have developed a method of collecting exhaled breath condensate pH continually from ventilated patients, which (1) takes samples from an exhaust port on the outside of the ventilator circuit, and (2) possesses no measurable resistance to the ventilator circuit (and, therefore the sampling procedure in no way affects the patient).
Now, additionally, we have performed the continuous collection process on 10 patients in the intensive care units, none of whom have had any ill effects from the collection process.
The placement of the exhaled breath condensate collection device on the ventilator exhaust port offers a simplified, accurate, and safe method of investigating the relationships between airway pH and various pulmonary inflammatory disease processes in intubated patients of all ages.
In order to further extend our study of airway pH in intubated subjects, we believe it is necessary to obtain more frequent exhaled breath condensate pH measurements from intubated subjects. To that end, we have developed a collection system that will also measure the pH of the collected exhaled breath condensate in a fashion similar to the methodology used for thousands of assays in our laboratory and other laboratories globally. This involves deaeration of the sample to remove carbon dioxide. In the lab environment, this is performed with Argon. In the ICU setting, we will accomplish the same effect by using wall oxygen.
The continuous exhaled breath condensate pH collection and assay system consists of a condenser attached to the exhaust port of the ventilator. The condenser is kept chilled to slightly above freezing temperature by a refrigeration system commonly employed in ICU settings. The collection device stays attached to the exhalation port of the ventilator continuously, for hours to days.
Collected exhaled breath condensate is channeled into two deaeration chambers, through which wall oxygen is bubbled (total flow of 1 liter/min). In the second deaeration chamber, a micro pH electrode is inserted. This pH electrode is attached to a pH recorder that has internal memory that can record essentially an infinite number of measurements, allowing for any length duration of monitoring. This recorder has been evaluated by clinical engineering for radio frequency and other interference and is cleared for hospital use.
After measurement of pH, exhaled breath condensate is channeled into a waste chamber.
The breath condensate collection system is maintained chilled by a "hospital grade" Electri-Cool II model 767 refrigerated cooling system (or near-equivalent) that is clinically approved for use in the intensive care units. This device is approximately 30 cm on a side, and is kept on a wheeled cart out of the way of any clinical activity.
Hypothesis to be Tested: Clearly state the objectives and hypotheses and clearly define the primary and any secondary outcome measures.
- Exhaled breath condensate pH will have greater within-hour variability in subjects with lung disease than in subjects intubated for non-pulmonary reasons.
- Exhaled breath condensate pH will rise prior to readiness for extubation in infants and toddlers requiring mechanical ventilation for acute bronchiolitis.
- A decline in exhaled breath condensate pH or an increase in exhaled breath condensate pH variability will predict the onset of pulmonary inflammatory processes (such as ventilator-associated pneumonia) in those who initially require mechanical ventilation for non-inflammatory reasons.
- Conditions
- Respiratory Distress Syndrome, Adult, Respiratory Syncytial Virus Infections, Pneumonia, Acute Lung Injury
- Keywords
- EBC pH, Airway acidification, Condensimetry, ARDS, RSV, ALI, Airway reconstruction
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Syncytial Virus Infections, Pneumonia, Acute Lung Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startDec 2004
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- John F Hunt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429637
- Sponsor's protocol ID
- 11618
- Status last verified
- Aug 2008
- First submitted
- 30 Jan 2007
- Last updated
- 7 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Continuous Exhaled Breath Condensate pH in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT00429637
- Acronym / sponsor ID
- 11618
- Conditions
- Respiratory Distress Syndrome, Adult, Respiratory Syncytial Virus Infections, Pneumonia, Acute Lung Injury
- Keywords
- EBC pH, Airway acidification, Condensimetry, ARDS, RSV, ALI, Airway reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Jan 2009 (estimated)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the possible prognostic relationship between exhaled breath condensate pH and clinical symptoms, it is quite plausible that exhaled breath condensate pH can prove useful in the intensive care unit. For example, if exhaled breath condensate pH falls prior to the onset of clinical symptoms, it is likely that it can be useful as an early marker, heralding the onset of various inflammatory lung diseases. Specifically, exhaled breath condensate pH could be used as a safe, non-invasive screening tool for Ventilator Associated Pneumonia. Similarly, just as changes in exhaled breath condensate pH might predict the onset of disease, exhaled breath condensate pH changes might also mark the progression or resolution of disease (e.g. alerting clinicians to possible readiness for extubation). Although such notions are hypothetical, they are beginning to be supported by anecdotal evidence.
Detailed description
The investigators have developed a method of collecting exhaled breath condensate pH continually from ventilated patients, which (1) takes samples from an exhaust port on the outside of the ventilator circuit, and (2) possesses no measurable resistance to the ventilator circuit (and, therefore the sampling procedure in no way affects the patient).
Now, additionally, we have performed the continuous collection process on 10 patients in the intensive care units, none of whom have had any ill effects from the collection process.
The placement of the exhaled breath condensate collection device on the ventilator exhaust port offers a simplified, accurate, and safe method of investigating the relationships between airway pH and various pulmonary inflammatory disease processes in intubated patients of all ages.
In order to further extend our study of airway pH in intubated subjects, we believe it is necessary to obtain more frequent exhaled breath condensate pH measurements from intubated subjects. To that end, we have developed a collection system that will also measure the pH of the collected exhaled breath condensate in a fashion similar to the methodology used for thousands of assays in our laboratory and other laboratories globally. This involves deaeration of the sample to remove carbon dioxide. In the lab environment, this is performed with Argon. In the ICU setting, we will accomplish the same effect by using wall oxygen.
The continuous exhaled breath condensate pH collection and assay system consists of a condenser attached to the exhaust port of the ventilator. The condenser is kept chilled to slightly above freezing temperature by a refrigeration system commonly employed in ICU settings. The collection device stays attached to the exhalation port of the ventilator continuously, for hours to days.
Collected exhaled breath condensate is channeled into two deaeration chambers, through which wall oxygen is bubbled (total flow of 1 liter/min). In the second deaeration chamber, a micro pH electrode is inserted. This pH electrode is attached to a pH recorder that has internal memory that can record essentially an infinite number of measurements, allowing for any length duration of monitoring. This recorder has been evaluated by clinical engineering for radio frequency and other interference and is cleared for hospital use.
After measurement of pH, exhaled breath condensate is channeled into a waste chamber.
The breath condensate collection system is maintained chilled by a "hospital grade" Electri-Cool II model 767 refrigerated cooling system (or near-equivalent) that is clinically approved for use in the intensive care units. This device is approximately 30 cm on a side, and is kept on a wheeled cart out of the way of any clinical activity.
Hypothesis to be Tested: Clearly state the objectives and hypotheses and clearly define the primary and any secondary outcome measures.
- Exhaled breath condensate pH will have greater within-hour variability in subjects with lung disease than in subjects intubated for non-pulmonary reasons.
- Exhaled breath condensate pH will rise prior to readiness for extubation in infants and toddlers requiring mechanical ventilation for acute bronchiolitis.
- A decline in exhaled breath condensate pH or an increase in exhaled breath condensate pH variability will predict the onset of pulmonary inflammatory processes (such as ventilator-associated pneumonia) in those who initially require mechanical ventilation for non-inflammatory reasons.
Study design
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any intubated patients, aged birth to adulthood, who are on a ventilator in any University of Virginia (UVA) intensive care unit.
Key exclusion criteria (1 listed)
- Control subjects may not be taking oral or inhaled steroids or have asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bacterial or viral pneumonitis, or adult respiratory distress syndrome (ARDS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Hunt, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Syncytial Virus Infections, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian K Walsh, BS, RRT (434-243-9324, bkw2j@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.